Two New Studies Show CDx Diagnostics‘ WATS3D Esophageal Biopsy Increases Detection of Residual and Recurrent Barrett’s Esophagus and Dysplasia in Post-Ablation Patients

ORLANDO, FL–(Marketwired – May 20, 2013) – CDx Diagnostics announced today that two new studies support use of its principal Wide Area Transepithelial biopsy with 3-Dimensional analysis (WATS3D) as an additional surveillance tool to detect residual Barrett’s Esophagus and dysplasia in patients who have received ablation therapy to eliminate these conditions. Barrett’s Esophagus is a condition that can result from chronic gastroesophageal reflux disease (GERD) and be a pre-cursor to esophageal cancer. The studies were presented in a poster session at Digestive Disease Week® (DDW®), taking place from May 18-21, 2013.

The WATS3D biopsy collects a wide area, disaggregated tissue specimen of the entire thickness of the epithelium being tested. This unique tissue specimen is then subjected to specialized, computer-assisted 3-dimensional analysis to pinpoint potentially abnormal cells for presentation to a specially trained GI pathologist.

One study (Abstract number Mo1912) “Wide Area Transepithelial Sampling Detects Barrett’s Metaplasia Missed by Forceps Biopsies After Ablation of Short and Long Segment Disease” led by Michael Smith, M.D., M.B.A., Medical Director of the Esophageal Program and Assistant Professor of Medicine, Temple University School of Medicine, concluded that adding WATS3D increased the overall detection of residual or recurrent Barrett’s Esophagus by 36%, and specifically increased the detection yield by 60% in long segment Barrett’s Esophagus post-ablation patients.

“These results underscore the need for new technologies that increase our ability to detect residual or recurrent Barrett’s Esophagus in these patients,” said Dr. Smith. “Our data show that WATS3D can play an important role in finding pre-cancerous cells we thought we had eradicated, even when standard methods fail to identify them.”

Another study (Abstract number Su1448) “Wide Area Transepithelial Sampling: An Adjunct to Surveillance in Barrett’s Esophagus Post Radiofrequency Ablation” led by Anthony Infantolino, MD, AGAF, FACG, FACP, Clinical Associate Professor, Jefferson University Hospitals, found that WATS3D detected discrepancies in both the upstaging and down-staging of pathological diagnoses.

“WATS3D provided valuable information that would not have been available with forceps biopsy alone,” said Dr. Infantolino. “These data add to the evidence base supporting WATS3D as an adjunctive technique for post-ablation surveillance of Barrett’s Esophagus.”

Diagnostic agreement between forceps biopsy and WATS3D was seen in 19 of the 23 patient cohort (82.6%). Of the four patients with discordant results, WATS3D upstaged two and down-staged two diagnoses. WATS3D detected one patient with recurrent focal intestinal metaplasia, and upstaged one low grade dysplasia to high grade dysplasia. WATS3D did not detect one patient with intestinal metaplasia (buried at the gastroesophageal junction) and one patient with low grade dysplasia (reported in only one out of nine forceps biopsy). No complications were reported.

About Barrett’s Esophagus and Esophageal Cancer
Many cases of esophageal adenocarcinoma (EA) are preceded by chronic heartburn. Some heartburn patients develop altered cell patches in their esophagus. A condition known as dysplasia occurs as Barrett’s esophagus progresses to Barrett’s-associated cancer. Dysplasia is considered a precancerous condition and should be monitored very closely to ensure the cells do not become cancerous. Dysplastic cells are very similar to cancer cells but have not yet acquired the ability to invade into tissue or metastasize. Esophageal cancer is now the fastest growing form of cancer in the U.S.

About CDx Diagnostics and the WATS3D biopsy
By combining the power of proprietary computer algorithms with confirmation from expert pathologists, the WATS3D biopsy delivers results that enable healthcare professionals to detect pre-cancerous cells earlier.

The WATS3D biopsy is developed by CDx Diagnostics (www.cdxdiagnostics.com), the world’s leader in the prevention of cancer of the oral cavity, pharynx, larynx and esophagus through early detection of their pre-cancerous precursors. Clinicians use the WATS3D biopsy instruments to collect, through minimally invasive procedures, a wide area, disaggregated tissue specimen of the entire thickness of the suspect epithelium. This unique tissue specimen is then subjected to specialized, computer-assisted laboratory analysis. In clinical trials, CDx Diagnostics’ WATS3D biopsy significantly increased the detection rate of Barrett’s esophagus in GERD patients as well as precancerous changes in esophageal tissue (dysplasia). The high sensitivity of WATS3D is due to the large tissue area sampled, and the proprietary 3-Dimensionial computer imaging system that is based on an algorithm developed as part of the U.S. Strategic Defense Initiative missile defense program.

About Digestive Disease Week
Digestive Disease Week® (DDW®) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW takes place May 18 – 21, 2013, at the Orange County Convention Center, Orlando, FL. The meeting showcases more than 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. More information can be found at www.ddw.org.